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Global Compliance

United States

Manage US DSCSA requirements for both lot level and serialized item traceability. TraceLink’s Integrate Once, Interoperate with Everyone™ architecture enables rapid onboarding and integration with suppliers and customers for the receipt and shipping of US DSCSA transactions. Comply with the saleable returns verification requirements. Facilitate managing serialization data at the edge of warehouse processes such as receiving, sampling, pick, pack, ship, and re-work.

Benefits

  • Lot and item level tracking. Manage transaction histories, information, and statements for product at the item and lot level.

  • Rapid trade partner onboarding. Use a network model to eliminate the need for point to point connections with trade partners.

  • Warehouse digitization. Digitize warehouse processes and eliminate manual and paper-based systems.

  • Saleable returns efficiency. Verify serial numbers for returned product to be resold against pharmaceutical manufacturer repositories or other VRS systems.

Applications

Product Track
Product Track provides wholesalers with functionality to receive, manage, and ship transaction information, histories, and statements in compliance with the Drug Supply Chain Security Act (DSCSA). Product Track verifies the inbound EDI 856 ASN for lot level and the EPCIS message for serialized product to ensure they include all of the required elements for compliance. Transactions are stored where they are searchable or readily available for inclusion in messages sent to downstream customers.

Edge Track
Edge Track provides wholesalers with functionality to manage serialization throughout warehouse processes. Whether receiving serialized or non-serialized product, Edge Track facilitates the data capture through mobile devices and communicates to the appropriate business systems — ERP, WMS, and serialization repository.

Product Information Manager
Product Information Manager provides verification functionality that wholesalers will use to verify serial numbers for returned product that will be later re-sold. Once the serial number is captured, the solution facilitates verifying that serial number against the defined verification repository. The repository may include the pharmaceutical manufacturer's repository or a third party verification router service. Verification results are immediately returned to the wholesaler so that operational processes are not delayed.

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